Dercher Enterprises, Inc., DBA Gordon Laboratories recalls MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box,

Recalled July 31, 2019 · FDA recall D-1528-2019 · Dercher Enterprises, Inc.,

Hazard

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content. · FDA Class II

Units

277 boxes

Sold at

Nationwide in the USA

Description

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

Product

MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

Manufacturer(s)

Dercher Enterprises, Inc., DBA Gordon Laboratories

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →